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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system,x-ray,extraoral source,digital
510(k) Number K120318
Device Name VIVI ERGON-X HF
Applicant
VIVI S.R.L.
via borgo santa
cristina ,12
imola,  IT 40026
Applicant Contact guido bonapace
Correspondent
VIVI S.R.L.
via borgo santa
cristina ,12
imola,  IT 40026
Correspodent Contact guido bonapace
Regulation Number872.1800
Classification Product Code
MUH  
Subsequent Product Code
EHD  
Date Received02/02/2012
Decision Date 03/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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